(29 days)
The Cordless coil is a receive type surface coil. When used in the MAGNETOM Concerto and C! MR systems, it is indicated for use as a when about in alle interese to produce transverse, sagittal, coronal and oblique images of internal structures of the brain and body surface. The images produced reflect the spatial distribution of protons exhibiting magnetic resonance. Spectra allow the molecules containing the nucleus under investigation to be distinguished. The NMR properties that determine the image and spectra appearance are spin density, spin-lattice relaxation time (T1), and spin-spin echo time (T2) of the corresponding nucleus. When interpreted by a trained physician, these images and spectra provide information that can be useful in making diagnoses.
The Cordless Coil. It is a set consisting of two coils. The coupling loop is connected with a cable and one receive coil is inductively coupled to the other.
The provided text describes a 510(k) summary for a Cordless Coil for MRI systems, focusing on its substantial equivalence to predicate devices rather than directly presenting explicit acceptance criteria and a detailed study proving performance against those criteria.
However, based on the information provided, we can infer the approach taken by the manufacturer to demonstrate safety and effectiveness for substantial equivalence.
Here's an analysis of the provided text in the context of your request:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics for the Cordless Coil. Instead, it asserts substantial equivalence to predicate devices. This implies that the performance of the Cordless Coil is expected to be as good as or similar to the predicate devices, without introducing new safety risks.
- Acceptance Criteria (Inferred): Performance (image quality, signal-to-noise ratio, spatial distribution of protons, T1/T2 characteristics that allow for diagnosis) to be similar to legally marketed predicate devices without introducing new safety risks.
- Reported Device Performance: The document states, "The Cordless Coil for MAGNETOM Concerto and C! described in this Premarket Notification has the same intended use and similar technical characteristics as the devices listed above. In summary, Rapid Biomedical and Siemens are of the opinion that the Cordless coil does not introduce any new safety risks and is substantially equivalent to, and performs as well as, the predicate devices." This is a qualitative assertion of equivalence rather than a quantitative performance report.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide any details about a specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) for evaluating the Cordless Coil's performance directly. The basis of substantial equivalence is comparison to predicate devices, rather than a de novo clinical study with a distinct test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since no distinct test set with ground truth is described, there's no information about the number or qualifications of experts used to establish ground truth. The intended use statement mentions "When interpreted by a trained physician, these images and spectra provide information that can be useful in making diagnoses," implying that trained physicians are the ultimate interpreters of the images, but this is not about establishing ground truth for a study.
4. Adjudication Method:
Given the lack of a described test set and ground truth establishment, there is no information on any adjudication method (e.g., 2+1, 3+1, none).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
There is no mention of an MRMC comparative effectiveness study being performed, nor any effect size regarding human reader improvement with or without AI assistance. This device is a hardware component (MRI coil), not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only) Performance Study:
There is no mention of a standalone algorithm performance study. This is a hardware device, not an algorithm.
7. Type of Ground Truth Used:
Since no specific performance study with a test set is described, there is no information regarding the type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample Size for the Training Set:
This device is a hardware component (MRI coil), not an AI/machine learning algorithm that requires a training set. Therefore, there is no information on a training set sample size.
9. How the Ground Truth for the Training Set Was Established:
As above, there is no information on how ground truth for a training set was established, as this is not an AI/ML device.
Summary of the Study (as described for substantial equivalence):
The "study" presented here is a substantial equivalence argument based on technical characteristics and intended use comparison to legally marketed predicate devices.
- Name of Study: Not explicitly named as a formal "study," but rather a 510(k) "Premarket Notification" demonstrating substantial equivalence.
- Objective: To demonstrate that the Cordless Coil for MAGNETOM Concerto and C! MR Systems is as safe and effective as existing predicate devices.
- Methodology (Inferred from 510(k) process): Comparison of the new device's design, materials, performance specifications (which are not detailed in this summary), and intended use against those of the predicate devices. The rationale is that if the new device has "the same intended use and similar technical characteristics" and "does not introduce any new safety risks," then it is substantially equivalent.
- Predicate Devices Used:
- Evidence for Equivalence: Conformance to FDA recognized NEMA Standards for performance and safety parameters, and IEC standard IEC 60601-2-33: 2002 for safety issues with Magnetic Resonance Imaging Devices.
- Conclusion: The manufacturer's opinion is that the Cordless coil does not introduce any new safety risks and is substantially equivalent to, and performs as well as, the predicate devices. The FDA concurred with this determination, as indicated by the clearance letter.
Essentially, for this type of medical device 510(k) submission, the "study" is the comprehensive documentation and comparison to predicate devices, rather than a clinical trial with specific performance metrics against an established ground truth. The "acceptance criteria" are implicitly met by demonstrating that the device is fundamentally similar to previously cleared devices and adheres to relevant safety standards.
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Section 1: 510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in This Sunmilling of 51 (tr). Sales) and 21 CFR § 807.92.
| I. General InformationDevice Name | Trade Name: Cordless coilClassification Name: Magnetic Resonance Diagnostic DeviceCFR Section: CFR § 892.1000Classification: Class IIProduct Code: LNH |
|---|---|
| Manufacturer | Rapid Biomedical GmbHTechnologiepark Wuerzburg-RimparKettelerstrasse 3-11D-97222 Rimpar, BayernGermany |
| Initial Importer/Distributor | Siemens Medical Solutions, Inc.51 Valley Stream ParkwayMalvern, PA 19355 |
| Registration Number | 2240869 |
| Contact Person | Ms. Ana LadinoTechnical Specialist, Regulatory AffairsSiemens Medical Solutions51 Valley Stream Parkway E-50Malvern, PA 19355Phone: (610) 448-1785Fax: (610) 448-1787Email: ana.ladino@siemens.com |
| Performance Standards | None established under Section 514 the Food, Drug, and Cosmetic Act. |
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II. Safety and Effectiveness Supporting Substantial Equivalence
Intended Use
The Cordless coil is a receive type surface coil.
When used in the MAGNETOM Concerto and C! MR systems, it is indicated for use as a when about in alle interese to produce transverse, sagittal, coronal and oblique images of internal structures of the brain and body surface.
The images produced reflect the spatial distribution of protons exhibiting magnetic resonance. Spectra allow the molecules containing the nucleus under investigation to be distinguished. The NMR properties that determine the image and spectra appearance are spin density, spin-lattice relaxation time (T1), and spin-spin echo time (T2) of the corresponding nucleus.
When interpreted by a trained physician, these images and spectra provide information that can be useful in making diagnoses.
Device Description
Device Deserplish
The Cordless Coil. It is a set consisting of two coils. The coupling loop is connected with a cable and one receive coil is inductively coupled to the other.
Substantial Equivalence
Rabid and Siemens believe that, within the meaning of the Safe Medical Devices Act of 1990, the cordless coil for MAGNETOM Concerto and MAGNETOM C! is substantially equivalent to :
| Coil Name | Premarket Notification | Clearance Date |
|---|---|---|
| Coils used with Siemens Medical SolutionsMAGNETOM Concerto | K003192 | 12/21/2000 |
| Coils used with Siemens Medical SolutionsMAGNETOM C! | K043030 | 12/09/2004 |
The Cordless Coil for MAGNETOM Concerto and C! described in this Premarket Notification has the same intended use and similar technical characteristics as the devices listed above. In summary, Rapid Biomedical and Siemens are of the opinion that the Cordless coil does not introduce any new safety risks and is substantially equivalent to, and performs as well as, the predicate devices.
General Safety and Effectiveness Concerns
The cordless coil for MAGNETOM Concerto and MAGNETOM C! will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the IEC standard for safety issues with Magnetic Resonance Imaging Devices, IEC 60601-2-33: 2002. This will assure that the performance of this device can be considered safe and effective with respect to the currently available MAGNETOM Concerto and C! systems.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Ana Ladino Technical Specialist, Regulatory Affairs Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway E50 MALVERN PA 19355
MAR 2 5 2005
Re: K050476 Trade/Device Name: Cordless Coil for MAGNETOM Concerto and MAGNETOM C! MR Systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device
Regulatory Class: II Product Code: MOS Dated: February 18, 2005 Received: February 24, 2005
Dear Ms. Ladino:
We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
KUS 04 76 510(k) Number (if known) __
Cordless Coil for MAGNETOM Concerto and MAGNETOM Device Name: C! MR Systems.
Indications for Use:
The Cordless coil is a receive type surface coil.
When used in the MAGNETOM Concerto and C! MR systems, it is indicated for use as a When wood in the nirrore to produce transverse, sagittal, coronal and oblique images of internal structures of the brain and body surface.
The images produced reflect the spatial distribution of protons exhibiting magnetic resonance. Spectra allow the molecules containing the nucleus under investigation to be distinguished. The NMR properties that determine the image and spectra appearance are spin distinguision. Inc relaxation time (T1), and the spin-spin echo time (T2) of the corresponding nucleus.
When interpreted by a trained physician, these images and spectra provide information that can be useful in making diagnoses.
(please do not write below this line- continue on another page if needed)
Concurrence of CDRH, Office of Device
Evaluation
Prescription Use_ V
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Nancy bradon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K050476
Traditional 510(k) Premarket Notification Cordless Coil for MAGNETOM Concerto and C! CONFIDENTIAL
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.